Optimising Innovator Sourcing for Bio-Similar Development

Conventional Medication has been used and abused by Humanity for over a century now
Human body has started becoming immune to conventional medication
Antibiotic resistance is at it’s all time high
The next frontier in medicines is Bio-Therapeutics Targeting of Cells at DNA and Gene level

What is Reverse planning ?
Conventional RnD approach do not work for Bio-similars development
Bio-similars are expensive to develop, clinical studies are more complex and Stability even more so.
Top down approach of planning the full RnD process, Trials, Studies and then looking for Comparators has led to looses of Millions of Dollors in:
- Excess stock
- Expired Stock
- Wrong Packs

Reverse Planning:
- Start by identifying your Destination Markets
- For Example a Bio-similar to be registered in EU needs a EU sourced comparator from Innovator with EU number of the pack.
- While a Bio-similar for registration in RoW markets will accept comparator from any markets as long as it’s from the innovator.
- This reverse planning can SAVE millions of Dollars in sourcing by selecting the right source markets.

Source Markets should be chosen based on your Destination markets
For Example if you plan to Target RoW Markets, there’s no point in souring products from US market
US products with NDC numbers are at least 3 time more expensive as compared to same brand in International packs
US stocks are difﬁcult to get, highly controlled, traced and the sheer cost makes the development process un-viable.
In contrast to this : An International pack from Europe / Eastern Europe is available at 1/3rd the cost, in Large quantities and with Pedigree Documents.

Market-Intelligence

Ultimate goal of any development is to SELL the product
Sell – Fast and First to Market
Sell – At Most competitive price
Example : India is a Right Hand Drive Country – Is there any point launching a Left Hand Drive Car here ?
Similarly if your destination is RoW – there’s no point in Sourcing of US / EU stock for RnD
Lack of reverse planning : Only increase development cost hence the END product COST
Lack of product availability from US / EU markets – delays development
And off course you are not FAST or First to market

Identify your Destination Markets First
Check availability, Pack descriptions, SPC etc… of your comparator in planning stage
Call for Pack photos, Pack Scans in planning stage
Estimate the Quantity, Frequency etc…. in advance
Understand availability issues for Comparators right in the beginning.
Tie up your source even before you start development process

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